Breaking News
August 18, 2018 - Theravance Biopharma Reports Positive Top-Line Four-Week Data from Phase 2 Trial of TD-9855 for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension
August 18, 2018 - Animations prove effective in accurately measuring pain
August 18, 2018 - Three faculty members appointed to endowed positions | News Center
August 18, 2018 - New technique detects, measures, analyzes unevenly charged biomolecules
August 18, 2018 - Brief exposures to stressors can be beneficial to cells, shows study
August 18, 2018 - UTHealth-led survey shows much work remains to increase safety of e-health records
August 18, 2018 - Researchers use super-resolution microscope to unravel secrets of deadly Nipah virus
August 18, 2018 - Scientists identify pathways that reveal insights into mechanism of lung cancer etiology
August 18, 2018 - FDA approves marketing of brainsway deep transcranial magnetic stimulation system for OCD
August 17, 2018 - OUHSC gets $20 million grant to advance research and patient care for Oklahomans
August 17, 2018 - Sperm morphology differs depending on qualities of male bird
August 17, 2018 - Texas A&M researchers develop clay-based platform to grow blood vessels
August 17, 2018 - FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years
August 17, 2018 - Caring for Concussions | NIH News in Health
August 17, 2018 - Team explores diabetes drug’s ability to treat RSV infection
August 17, 2018 - New imaging technique can spot tuberculosis infection in an hour | News Center
August 17, 2018 - PolyU researchers design new self-fitting scaffold to induce bone regeneration
August 17, 2018 - CartiHeal and LSU Health successfully enroll first two patients in Agili-C IDE pivotal study
August 17, 2018 - Less-invasive options are slowing disease progression in glaucoma patients
August 17, 2018 - Researchers discover new promising target point for cancer and diabetes therapies
August 17, 2018 - Podcast: KHN’s ‘What the Health?’ See you in court!
August 17, 2018 - New mobile phone application enables early detection of cerebral ictus
August 17, 2018 - UK’s leading sight loss charity invites applications from brightest minds in ophthalmic research
August 17, 2018 - Researchers produce artificial placenta model that closely resembles natural organ
August 17, 2018 - FDA Alert: Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers
August 17, 2018 - Researchers discover why sepsis from a staph infection causes organ failure
August 17, 2018 - Revealed: The molecular mechanism underlying hypertrophic cardiomyopathy | News Center
August 17, 2018 - New modeling studies highlight urgent need for effective drug policy reforms to prevent HIV
August 17, 2018 - Research explores relationship between personal history of infectious fever and cancer risk
August 17, 2018 - Study finds rise in cases of progressive massive fibrosis among U.S. coal miners
August 17, 2018 - NEDBELS project examines impact of neurodiversity concept on legal systems
August 17, 2018 - Seeking solutions to treat scleroderma
August 17, 2018 - Statins may improve conditions of people with rare lung disease
August 17, 2018 - Study finds why some people with brain markers of Alzheimer’s never develop dementia
August 17, 2018 - Life Biosciences contributes $100,000 to fund its biomedical innovation course on aging
August 17, 2018 - Researchers develop a set of health outcome measures for children with complex medical situations
August 17, 2018 - Many Americans Not Being Assessed for Depression
August 17, 2018 - Scientists report setbacks in quest for AIDS cure
August 17, 2018 - Christopher Gardner busts myths about milk | News Center
August 17, 2018 - Bacterial activity in child’s mouth may serve as biomarkers for autism spectrum disorder
August 17, 2018 - Scripps Research scientists uncover new approach for treating thrombocytopenia
August 17, 2018 - Mathematical model shows the influence of human behavior on spread of infectious diseases
August 17, 2018 - Valley Hospital achieves Magnet recognition for fourth consecutive time
August 17, 2018 - Researchers describe link between poor oocyte development and oxidative stress in obese mice
August 17, 2018 - Hospitals battle for control over fast-growing heart-valve procedure
August 17, 2018 - AHA: Home-Delivered Meals Keep Heart Failure Patients Out of Hospital
August 17, 2018 - In Southern Mozambique, only half of people diagnosed with HIV enroll in medical care
August 17, 2018 - Researchers discuss techniques to help combat growing epidemic of obesity
August 17, 2018 - Researchers develop novel statistical method to evaluate gene-to-gene interactions linked with cancer
August 17, 2018 - Island Fertility joins Stony Brook Community Medical to provide comprehensive fertility care
August 17, 2018 - Study shows link between thinning of the retina and early sign of Parkinson’s disease
August 17, 2018 - Digital birth control app gets FDA nod
August 17, 2018 - FDA grants approval for first generic version of epinephrine auto-injector
August 17, 2018 - Federal advisory group publishes recommendations on prevention of acute, chronic pain
August 17, 2018 - 3D-printed human body parts to be used as teaching aids for surgical training
August 17, 2018 - U.S. murder, suicide rates climbing again
August 17, 2018 - This is your brain on… roller coasters?
August 17, 2018 - Report discusses whether all newborns should undergo genetic sequencing
August 17, 2018 - UCR receives 2018 Inspiring Programs in STEM Award from INSIGHT Into Diversity magazine
August 17, 2018 - Researchers publish new paper on developing vaccine candidates for Helminthic parasites
August 17, 2018 - Researchers develop new method to diagnose broad range of cancers using malaria protein
August 17, 2018 - Female mosquitoes quickly evolve selective mating behavior when faced with threats
August 17, 2018 - FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
August 17, 2018 - Resistance training and exercise motivation go hand-in-hand
August 17, 2018 - A lesson for future doctors: Listen to and learn from your patients
August 17, 2018 - NUS study discovers a bidirectional regulator and shines light on A-to-I RNA editing in cancer cells
August 17, 2018 - Research shows link between high blood levels of omega-3s and better brain function in children
August 17, 2018 - Researchers propose new theory for how rare gene mutations cause Alzheimer’s disease
August 17, 2018 - New project to combat DMD-related fibrosis receives major funding boost
August 17, 2018 - Digital psychiatric therapy can ‘rewire’ the brain in children with ADHD, study shows
August 17, 2018 - Psychologist to assess how the brain maintains precise short-term and long-term memories
August 17, 2018 - Eating white button mushrooms could improve regulation of glucose in the liver
August 17, 2018 - Scientists identify mutational signatures in ovarian cancer
August 17, 2018 - Sun Pharma receives U.S. FDA approval for CEQUA to treat patients with dry eye disease
August 17, 2018 - Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
August 17, 2018 - Study shows DNA methylation related to liver disease among obese patients
August 17, 2018 - Life on the border: Back at Stanford, ready to pitch in
August 17, 2018 - New device for accurately placing hemodialysis catheters on kidney patients
August 17, 2018 - New strategy accelerates, automates process of prototype molecule optimization
August 17, 2018 - Study finds role of autoimmunity in development of COPD
FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer

FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer

image_pdfDownload PDFimage_print

18 April 2018 — AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. The approval is based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “Today’s FDA approval of Tagrisso in the 1st-line setting is an exciting milestone for patients and our company. Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumors growing or spreading.”

Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial, from Winship Cancer Institute of Emory University, Atlanta, said: “The approval of osimertinib (Tagrisso) in the 1st-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm. Osimertinib (Tagrisso) provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors.”

The FLAURA trial compared Tagrisso to current 1st-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib, in previously untreated patients with locally advanced or metastatic EGFR-mutated (EGFRm) NSCLC. Tagrisso met the primary endpoint of progression-free survival (PFS) (see table below). PFS results with Tagrisso were consistent across all pre-specified patient subgroups, including in patients with or without central nervous system (CNS) metastases. Overall survival data were not mature at the time of the final PFS analysis.

*Confirmed responses

Safety data for Tagrisso in the FLAURA trial were in line with those observed in prior clinical trials. Tagrisso was generally well tolerated, with Grade 3 or higher adverse events (AEs) occurring in 34% of patients taking Tagrisso and 45% in the comparator arm. The most common adverse reactions (≥20%) in patients treated with Tagrisso were diarrhea (58%), rash (58%), dry skin (36%), nail toxicity (35%), stomatitis (29%), fatigue (21%) and decreased appetite (20%).

In the US, Tagrisso is already approved for the 2nd-line treatment of patients with metastatic EGFRm NSCLC, whose disease has progressed on or after a 1st-line EGFR-TKI therapy and who have developed the secondary T790M mutation, as detected by an FDA-approved test. In 2017, Tagrisso was granted Breakthrough Therapy and Priority Review designations by the US FDA in the 1st-line treatment setting. Tagrisso is under regulatory review in the European Union and Japan for use in the 1st-line treatment setting with regulatory decisions anticipated in the second half of 2018.

Tagrisso received its first approval for 1st-line use based on the FLAURA data in Brazil in patients with metastatic EGFRm NSCLC on April 16, 2018.

AstraZeneca partnered with Roche Molecular Systems to develop the cobas® EGFR Mutation Test v2 as the companion diagnostic for TAGRISSO. The diagnostic is simultaneously approved as a tissue- or plasma-based test, to identify patients with EGFRm NSCLC who are eligible for 1st-line treatment with TAGRISSO and as a tissue or plasma-based test to identify patients with EGFR T790M mutation-positive NSCLC whose disease has progressed on a 1st-line EGFR TKI.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths in the US, more than breast, prostate and colorectal cancers combined. Approximately 7-23% of patients in Western populations, and 30-50% of patients in Asia have tumors that contain activating mutations in epidermal growth factor receptor (EGFR). These patients are particularly sensitive to treatment with EGFR tyrosine kinase inhibitors (TKIs), which block the cell-signaling pathways that drive the growth of tumor cells. Tumors almost always develop resistance to EGFR-TKI treatment, however, leading to disease progression. Approximately half of patients develop resistance to approved EGFR-TKIs such as gefitinib, erlotinib and afatinib due to the EGFR T790M resistance mutation. There is also a need for medicines with improved central nervous system (CNS) efficacy, since approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.

About Tagrisso (osimertinib)

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have been approved in the US and Brazil for 1st-line EGFRm advanced NSCLC, and in more than 75 countries including the US, EU, Japan and China for patients with EGFR T790M mutation-positive advanced non-small cell lung cancer.

Tagrisso was originally granted Accelerated Approval by the US Food and Drug Administration (FDA) in 2015 for the 2nd-line treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR-TKI therapy. In March 2017, the FDA followed up with a full, confirmatory approval based on data from the Phase III AURA3 trial.

Tagrisso is also being investigated in the adjuvant setting and in combination with other treatments.

About the FLAURA Trial

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg once daily vs. standard-of-care epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. The trial was double-blinded and randomized, with 556 patients across 29 countries.

About the cobas® EGFR Mutation Test v2

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of 42 defined mutations of the EGFR gene in exons 18-21, including L858R, exon 19 deletions, and T790M mutations. This in-vitro diagnostic (IVD) test is the first and currently the only FDA-approved EGFR test to include both tissue and liquid biopsy (plasma) as patient sample types for testing.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient with lung cancer. We have three approved medicines and a growing pipeline that targets genetic changes in tumor cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth platform for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

Source: AstraZeneca

Posted: April 2018

Related Articles:

Tagrisso (osimertinib) FDA Approval History

Tagged with:

About author

Related Articles